For patients with

Relapsing Forms of Multiple Sclerosis

Experience

Mylan's Glatiramer Acetate Injection,

an FDA-Approved therapeutic equivalent to Copaxone®

What Is Glatiramer Acetate?

Glatiramer Acetate is a prescription medication that can be injected subcutaneously to treat relapsing forms of multiple sclerosis (MS).

Every dose of Glatiramer Acetate is composed of a complex mixture of polypeptides containing four naturally occurring amino acids:

  • L-glutamate
  • L-lysine
  • L-alanine
  • L-tyrosine

Some scientists think that MS may result when the body’s immune system attacks the myelin sheath that surrounds and protects nerve cell axons.1 Although the mechanism of action of Glatiramer Acetate is not fully known, there is evidence that it may help reduce MS relapses by interrupting this immune system attack.1

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What Is Mylan’s Glatiramer Acetate Injection?

Glatiramer Acetate Injection from Mylan is an FDA-approved therapeutic equivalent to Copaxone® (glatiramer acetate injection), available in two doses

  • 20
    mg/mL

    for once-daily
    Injection

  • 40
    mg/mL

    3-times-a-week
    Injection

This means that Glatiramer Acetate Injection from Mylan may be substitued for the equivalent dose of Copaxone® and may be expected to have a comparable safety and efficacy profile.2

Like Copaxone®, Glatiramer Acetate Injection from Mylan is available by prescription only, for injection under the skin.3

A Complex Drug, But Not a Biologic

You may have seen Mylan’s Glatiramer Acetate Injection incorrectly referred to as a biologic in articles, conference presentations or posts on the web.

According to the FDA, a biologic is a protein derived from living material used to treat or cure disease. Because the polypeptides that make up Glatiramer Acetate are manufactured in the lab, it is not classified as a biologic.4

INDICATION

GLATIRAMER ACETATE INJECTION is a prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis (MS).

IMPORTANT SAFETY INFORMATION

Do not take GLATIRAMER ACETATE INJECTION if you are allergic to glatiramer acetate or mannitol.

Some patients report a short-term reaction right after injecting glatiramer acetate. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection. Call your doctor right away if you have any of these symptoms and do not give yourself more injections until your doctor tells you to.

Chest pain may occur either as part of the immediate post-injection reaction or on its own. This pain usually only lasts a few minutes. You may experience more than one such episode, usually beginning at least one month after starting treatment. Tell your doctor if you experience chest pain.

A permanent indentation under the skin (lipoatrophy and, rarely, death of your skin tissue also referred to as necrosis) at the injection site may occur due to local destruction of fat tissue. Be sure to follow your doctor’s instruction on how to use glatiramer acetate injection and be sure to choose a different injection site each time you use glatiramer acetate injection.

The most common side effects in studies of GLATIRAMER ACETATE INJECTION are redness, pain, swelling, itching, or a lump at the site of injection, rash, shortness of breath, and flushing. These are not all the possible side effects of GLATIRAMER ACETATE INJECTION. For a complete list, ask your doctor or pharmacist. Tell your doctor about any side effects that you have while taking GLATIRAMER ACETATE INJECTION.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, Patient Information Leaflet, and Instructions for Use for Glatiramer Acetate Injection 20 mg/mL or Glatiramer Acetate Injection 40 mg/mL.

INDICATION

MORE LESS

GLATIRAMER ACETATE INJECTION is a prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis (MS).

IMPORTANT SAFETY INFORMATION

Do not take GLATIRAMER ACETATE INJECTION if you are allergic to glatiramer acetate or mannitol.

Some patients report a short-term reaction right after injecting glatiramer acetate. This reaction can involve flushing (feeling of warmth


IMPORTANT SAFETY INFORMATION

Do not take GLATIRAMER ACETATE INJECTION if you are allergic to glatiramer acetate or mannitol.

Some patients report a short-term reaction right after injecting glatiramer acetate. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection. Call your doctor right away if you have any of these symptoms and do not give yourself more injections until your doctor tells you to.

Chest pain may occur either as part of the immediate post-injection reaction or on its own. This pain usually only lasts a few minutes. You may experience more than one such episode, usually beginning at least one month after starting treatment. Tell your doctor if you experience chest pain.

A permanent indentation under the skin (lipoatrophy and, rarely, death of your skin tissue also referred to as necrosis) at the injection site may occur due to local destruction of fat tissue. Be sure to follow your doctor’s instruction on how to use glatiramer acetate injection and be sure to choose a different injection site each time you use glatiramer acetate injection.

The most common side effects in studies of GLATIRAMER ACETATE INJECTION are redness, pain, swelling, itching, or a lump at the site of injection, rash, shortness of breath, and flushing. These are not all the possible side effects of GLATIRAMER ACETATE INJECTION. For a complete list, ask your doctor or pharmacist. Tell your doctor about any side effects that you have while taking GLATIRAMER ACETATE INJECTION.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, Patient Information Leaflet, and Instructions for Use for Glatiramer Acetate Injection 20 mg/mL or Glatiramer Acetate Injection 40 mg/mL.